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eligibility_summary
Eligible: adults 18–70 with pathologically confirmed, initially resectable locally advanced head/neck SCC planned for surgery, HPV status by p16, ZPS <2, adequate organ function, able to consent/comply, able to tolerate neoadjuvant anti‑PD‑1, anti‑EGFR, and radiotherapy. Exclude: illnesses hindering safety/adherence, unable to receive RT, chronic systemic steroids ≥20 mg prednisone, autoimmune diseases.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests neoadjuvant combinations in locally advanced HNSCC: 1) PD-1 monoclonal antibody (immune checkpoint inhibitor) + taxane–platinum (TP) chemotherapy ± stereotactic body radiotherapy (SBRT), 2) a separate arm adds cetuximab (anti‑EGFR monoclonal antibody). Mechanisms: • PD‑1 mAb (drug, immunotherapy) blocks PD‑1/PD‑L1 to reinvigorate exhausted tumor‑specific T cells and sustain systemic antitumor immunity. • TP chemo (drugs, cytotoxics): taxane stabilizes microtubules to arrest mitosis, platinum crosslinks DNA, causing apoptosis, both can induce immunogenic cell death and enhance antigen presentation. • SBRT (radiation): causes DNA damage, releases tumor antigens, upregulates MHC‑I, and activates cGAS‑STING, promoting T‑cell priming (“in situ vaccine”). • Cetuximab (drug, mAb): blocks EGFR signaling (RAS/MAPK, PI3K/AKT) and mediates ADCC via NK cells. Targeted cells/pathways: PD‑1 pathway on T cells (especially CD8+), tumor EGFR, tumor microtubules/DNA, antigen‑presenting cells (DCs), NK cells, and radiation‑induced innate sensing (cGAS‑STING).